FDA 510(k) clearances — page 114
clearances on record, most recent first.
Clearances — page 114
11,301–11,400 of 176,479- K222926 — Arm Blood Pressure Monitor, Model Name:111, Arm Blood Pressure Monitor, Model Name: B1681, Arm Blood Pressure Monitor, Model Name: B1682, Arm Blood Pressure Monitor, Model Name: B1683
- K223858 — Lexa MINI (RIS-303, RIS-305)
- K230351 — LED Facial Mask
- K230615 — Electric Scooter (Model: S3312)
- K230616 — Polyguard and Polyshield Safety IV Catheters
- K230637 — Wattson temporary pacing guidewire (2250)
- K230989 — Rod Registration Frame
- K231017 — Panther Fusion AdV/hMPV/RV Assay
- K203245 — Bladder EpiCheck DNA extraction kit, NX899090-01C, Bladder EpiCheck test kit, NX899090-02C, Bladder EpiCheck Software, NX899090-03C
- K213280 — BD Kiestra Methicillin-resistant Staphylococcus aureus (MRSA) Application, BD Kiestra MRSA App
- K220290 — Revitalair 430+
- K220322 — Pollogen STOP U Model UXV Device
- K220713 — Sol-Guard Auto-disable Syringe
- K221798 — Finger Pulse Oximeter, Model: X1906P
- K222097 — OLYMPIC Deformity Band System
- K222388 — swiftPro System
- K222847 — Ceramic Brackets Orthometric
- K223430 — ProLift Micro Expandable Spacer System
- K223756 — SimPro Now, GentleCath Hydrophilic
- K223771 — Lumify Diagnostic Ultrasound System
- K223805 — Agnes
- K230082 — Auto Segmentation
- K230266 — Orchid Safety Release Valve
- K230340 — Lucas Plus
- K230530 — SOZO Pro
- K230531 — SOZO Pro
- K230619 — Hubly Electric Drill (H100)
- K230653 — Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System, JOURNEY BCS and II Knee Systems, JOURNEY II CR Knee System, JOURNEY II Uni Knee System, Journey II UK Knee System, JOURNEY II XR Bi-Cruciate Retaining Knee System, JOURNEY PFJ System, JOURNEY Uni Knee System, Legion Hinge Total Knee System, Legion Total Knee System, ZUK Unicompartmental Knee System, ENGAGE Partial Knee System and Porous Patella and Porous Tibial Baseplates
- K230960 — DLP Silicone Coronary Artery Ostial Cannulae
- K230994 — Alinity i STAT High Sensitivity Troponin-I
- K212743 — MedSchenker Smart Transport Medium (STM15-A/STM20-A/STM30-A/SCS30-A) System
- K222421 — Sphincterotome
- K223758 — Epione
- K223843 — FloPatch FP120
- K230123 — Apollo Knotless Suture Anchor
- K230203 — Dentis I-FIX Abutment
- K230655 — PEEK RCI Screw; Bio-Composite Screw; SignaLoc Screw
- K230934 — ViewFlex Eco Reprocessed ICE Catheter
- K230938 — ARIX Humerus System
- K230948 — BFlex 2 Slim 3.8 Single-Use Bronchoscope
- K212579 — FortiShield (Biosynthetic Wound Matrix)
- K221779 — ASEPT Peritoneal Drainage System
- K223495 — Zeolite Hemostatic Cotton
- K223511 — Excella Navigation Instruments
- K223529 — PressON Spinal Fixation System
- K223907 — NuEra Tight RF Model APMD145.M70-US
- K230119 — 3D Anatomic Model
- K230292 — Samsung ECG Monitor Application with Irregular Heart Rhythm Notification
- K230606 — AcQMap® High Resolution Imaging and Mapping System
- K230614 — Cortium
- K230880 — CoreLink Navigation Instruments
- K230912 — Artix BG
- K230957 — TriSalus TriNav® LV Infusion System
- K230977 — SIS System
- K221870 — CarnaLife Holo
- K222416 — RIA Safeguard
- K223182 — Arial Dental, Mistral Dental Amalgam, World Work Dental Amalgam, BMS Non Gamma 2 Alloy, Flexi Alloy, Hi-S Alloy, WW Dental Amalgam, Hi - Mix, Non Gamma 2 Alloy
- K223595 — vPATCH
- K230643 — CP620G LCD monitor, CP620 LCD monitor
- K213825 — Oxygen Concentrator model 8F-3A, Oxygen Concentrator model 8F-5A
- K220677 — Kurin Blood Culture Collection Set with Kurin Lock Technology
- K221390 — BNLE Access Guidewire
- K222004 — INTEGRATE -C Interbody Fusion System
- K222636 — ET Abutment System
- K222934 — Nanox.ARC
- K223634 — Customized Abutment
- K223677 — Titanium Abutment Blank Nobel Biocare N1 TCC
- K223862 — Hair Boom 69, Hair BoomAir, Hair Boom, Ulike Hair UpUp
- K230042 — Q-Rejuvalight Pro Facewear (Model: P19-0023)
- K230058 — Bladeless Trocar Artemis Lap Cannula
- K230480 — Weck Auto Endo5 5mm Automatic Endoscopic 35cm Applier (AE05ML)
- K230597 — Aduro Comb (Model: SZ-22, SZ-22A, SZ-22B)
- K230600 — VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364) +1 more
- K230908 — Hand Trauma Threaded Nail System
- K230972 — Ingenia Elition and MR 7700 MR Systems
- K213078 — Myolift QT
- K221963 — Cumulus Functional Neurophysiology Platform
- K221983 — Biodegradable Powder Free Nitrile Examination Glove, Blue Color, Biodegradable Powder Free Nitrile Examination Glove, Blue Violet Color, Biodegradable Powder Free Nitrile Examination Glove, Green Color
- K222352 — Epildream HP 4000 MED
- K222381 — PeriPRO Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating System
- K222694 — EmPro EPS (EP4514C-190, EP6514C-190); Nanoparasol EPS (PNP4514C-190,PNP6514C-190)
- K223210 — ClotTriever XL Catheter
- K223212 — Precision DL
- K223398 — Gastric Alimetry System
- K223520 — UNIDRIVE SIII System
- K223734 — ENT EM
- K223892 — DentMix VPS Impression Material
- K230272 — Renuvion® APR Handpiece
- K230539 — ArtiSential Laparoscopic Instruments-Electrodes
- K230547 — PlumePen Elite Surgical Smoke Evacuation Pencils, PlumePen Pro Surgical Smoke Evacuation Pencil, PlumePen Ultra Surgical Smoke Evacuation Pencils, PenAdapt Electrosurgical Pencil Adapter, SnapEvac Electrosurgical Pencil Adapter
- K230844 — Identity Imprint Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate Sacrificing (CS) Insert
- K230845 — 32HL512D, 31HN713D, 32HQ713D
- K230911 — Braun Skin i.expert
- K222548 — Endo Motor
- K222584 — EVIS X1 VIDEO SYSTEM CENTER OLYMPUS CV-1500, COLONOVIDEOSCOPE OLYMPUS CF-HQ1100DL/I, GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF-1100
- K222996 — Access PCT
- K223868 — PYXIS 3D Titanium Cage System
- K223932 — SafeAir combi (SFR-combi-US)
- K230499 — ArtiSential Laparoscopic Instruments-Electrodes
- K230552 — MR DWI/FLAIR Measurement V1.0
Data sourced from openFDA. This site is unofficial and independent of the FDA.